Catalog Number

-

Brand Name

Emvera

Version/Model Number

Diolux

Device Commercial Distribution Status

In Commercial Distribution

Commercial Distribution End Date

-

Issuing Agency

In GS1

MRI safety Status

Labeling does not contain MRI Safety Information

Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)

-

Device labeled as "Not made with natural rubber latex"

Yes

For Single-Use

-

Prescription Use (Rx)

Yes

Over the Counter (OTC)

-

Kit

-

Combination Product

-

Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)

-

FDA Premarket Submission

K123257

Product Code

GEX

Product Code Name

Powered Laser Surgical Instrument

Public Device Record Key

5c23e837-aacd-4fd0-a5ae-78d8c9440dc4

Public Version Date

April 01, 2019

Public Version Number

3

DI Record Publish Date

November 28, 2016

Package DI Number

None

Quantity per Package

-

Contains DI Package

-

Package Discontinue Date

-

Package Status

-

Package Type

-